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PET/CT Scans During Lung Cancer Chemoimmunotherapy and Radiation

This study is looking at how Positron Emission Tomography (PET) and Computed Tomography (CT) scans change when patients with stage IV (advanced) non-small cell lung cancer are treated with standard chemotherapy, immunotherapy, and radiation therapy. Researchers want to see if changes in these scans can help predict how well the cancer responds to treatment. You may be able to join if you have stage IV or recurrent non-small cell lung cancer and have not yet received chemotherapy or immunotherapy for your advanced disease. The study aims to enroll 80 participants. The main goal is to measure the rate of disease progression after one year.

Study design
This is an interventional study with a planned enrollment of 80 participants. The phase of the study is not specified.
What's involved
You would undergo PET/CT scans before and during chemoimmunotherapy, and before and after radiation therapy. You would also provide blood samples and may have MRI scans if your doctor thinks they are needed.
Compensation
Not stated in the trial record.
Follow-up
The study measures disease progression at one year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04151940

PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer

Recruiting
NAAges 18+Interventional
University of Washington
~80 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Positron Emission TomographyComputed TomographyChemotherapyImmunotherapyRadiation TherapyBiospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Actuarial disease progression rate
Measured over At 1 year

Conditions

Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8

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Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Lei Deng, MD · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

Stephen R. Bowen, PhD
[email protected]
206-543-6559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer \[AJCC\]/Union for International Cancer Control \[UICC\] 8th edition for staging)
Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging (MRI)
Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor
Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion
Subjects must be ≥ 18 years of age
Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Creatinine =\< 2 mg/dL or creatinine clearance \> 50 mL/min
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5x institutional upper limit of normal
Total bilirubin =\< 1.5 mg/dL
Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (\>= 1500 per mm\^3)
Platelet count \>= 100 x 10\^9/L (\>=100,000 per mm\^3)
Capability to understand and comply with the protocol requirements and signed informed consent documents

Exclusion

Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed \>= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)
Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
Has any serious or uncontrolled active infection that could create false positives on a PET/CT scan, in the opinion of the treating investigator
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)
Has known, active, and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day

What this trial measures

  • Actuarial disease progression rateAt 1 year

    Will be compared between high-risk and low-risk subgroups of patients based on positron emission tomography/computed tomography imaging biomarker changes using a two-sample proportionality test.